Senior Quality Engineer – Medical Devices

Regulatory Jobs; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Chicago seeks a Quality/Engineering professional to set basic quality standards and lead development of testing methods while guiding design control activities to ensure regulatory compliance.

You will design experiments, apply SPC, manage CAPA/SCAR with suppliers, and prepare 510K-related documentation in collaboration with Regulatory Groups; travel up to 15% may be required.

Qualifications

• Bachelor’s degree in engineering, science, math or related technical field.
• Minimum 4 years of experience in quality or engineering.
• Experience with government/industry quality codes (e.g., 21 CFR 820, ISO13485).
• Strong MS Office and advanced Excel skills.
• Willingness to travel up to 15%.

Responsibilities

• Develop and implement methods for process control and validation.
• Design experiments and apply SPC to analyze data.
• Lead supplier quality initiatives and CAPA/SCAR programs.
• Prepare design control, risk management, and CE technical files.
• Ensure compliance with domestic and international regulations and perform design document reviews.
• Lead investigations of non-conformances and corrective actions.

Skills

Independent work

Time management

Problem solving

Team leadership

MS Office

Excel (Pivot tables)

Travel readiness

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office

Job description

Medline Industries, LP in Chicago seeks a Quality/Engineering professional to set basic quality standards and lead development of testing methods while guiding design control activities to ensure regulatory compliance.

You will design experiments, apply SPC, manage CAPA/SCAR with suppliers, and prepare 510K-related documentation in collaboration with Regulatory Groups; travel up to 15% may be required.